The following data is part of a premarket notification filed by Deltex Medical with the FDA for Dp240 240 Hour Doppler Probe.
| Device ID | K052989 |
| 510k Number | K052989 |
| Device Name: | DP240 240 HOUR DOPPLER PROBE |
| Classification | Probe, Blood-flow, Extravascular |
| Applicant | DELTEX MEDICAL TERMINUS RD. Chichester, West Sussex, GB Po19 8tx |
| Contact | Lawrence Brookfield |
| Correspondent | Lawrence Brookfield DELTEX MEDICAL TERMINUS RD. Chichester, West Sussex, GB Po19 8tx |
| Product Code | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-24 |
| Decision Date | 2006-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 5055679400748 | K052989 | 000 |